FDA Issues Complete Response Letter to Outlook Therapeutics' ONS-5010 BLA.

Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA for its resubmitted biologics license application (BLA) for ONS-5010. The CRL stated that the FDA cannot approve the application in its current form due to a lack of substantial evidence of effectiveness. The company plans to work with the FDA to address the issues and will host a conference call today to discuss the matter further.

Outlook Therapeutics, Inc. (OTLK) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA™, an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The CRL stated that the FDA cannot approve the application in its current form due to a lack of substantial evidence of effectiveness.

The FDA's decision hinges on the failure of the NORSE EIGHT trial to meet its primary endpoint, while acknowledging that the NORSE TWO trial did meet its efficacy endpoint. The FDA is requesting additional confirmatory evidence of efficacy before considering approval. This regulatory setback presents a significant challenge for Outlook Therapeutics, requiring the company to conduct new clinical trials, which will involve substantial time and capital investment.

Despite this setback, Outlook Therapeutics has secured Marketing Authorization for LYTENAVA™ in both the European Union and the United Kingdom. The drug is commercially available in Germany and the UK, providing a potential revenue stream while the company addresses the FDA's concerns. LYTENAVA™ is positioned as the first purpose-formulated bevacizumab for intravitreal use in wet AMD, aiming to provide a regulated alternative to compounded Avastin.

The company plans to work with the FDA to address the issues and will host a conference call today to discuss the matter further. The conference call will provide an opportunity for investors and financial professionals to gain additional clarity on the company's regulatory strategy and potential paths to approval.

This regulatory outcome presents a substantial challenge for Outlook Therapeutics, but the company's European commercialization strengthens its overall market position and potentially provides financial resources to pursue additional clinical development required by the FDA.

References:
[1] https://trial.medpath.com/news/326c0dc7e46c7fe7/outlook-therapeutics-awaits-critical-fda-decision-for-wet-amd-treatment-ons-5010
[2] https://www.stocktitan.net/news/OTLK/outlook-therapeutics-provides-regulatory-update-on-u-s-food-and-drug-nbyjrm2bh7f4.html